Ethicon, Inc.: Medical Device Recall in 2024 - (Recall #: Z-2147-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable. PRODUCT CODE: PDP304H PDP316H PDP341H

Product Classification:

Class II

Date Initiated: May 10, 2024

Date Posted: June 26, 2024

Recall Number: Z-2147-2024

Event ID: 94643

Reason for Recall:

Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

Status: Ongoing

Product Quantity: 45828 units

Code Information:

GTIN: 10705031047976 10705031048027 10705031048119 PRODUCT CODE PRODUCT LOTS PDP304H TLMJLZ PDP316H UAMKDC PDP341H UBMCZA

Distribution Pattern:

Worldwide distribution - US Nationwide including PR and the countries of AR, AU, AU, BE, BR, CA, CA, CL, CN, CO, CR, EC, IL, JP, JP, KW, MX, NZ, PA, PR, PR, SA, SG, UY, ZA.

Voluntary or Mandated:

Voluntary: Firm initiated